Description
Status H. Pylori is a rapid test for the qualitative detection of anti-Helicobacter pylori antibodies in human whole blood, serum or plasma. It is CLIA waived for whole blood, runs from a fingerstick, and returns results in 10 minutes with a single-reagent procedure.
- Fingerstick Convenience – Only 25 microliters of whole blood are needed, so the test runs from a fingerstick at the point of care.
- Results in 10 Minutes – The single-reagent procedure reads fast enough to inform the same visit's plan.
- Published Sensitivity – LifeSign reports 95.9 percent sensitivity with 91.6 percent overall agreement to biopsy histology.
Fingerstick H. Pylori Antibody Testing in 10 Minutes
Dyspepsia workups stall when H. pylori status waits on a send-out laboratory. This cassette detects anti-H. pylori antibodies qualitatively from whole blood, serum or plasma, with the whole blood format carrying CLIA waived status. The fingerstick collection needs only 25 microliters of whole blood, or 10 microliters of serum or plasma, and the procedure uses a single reagent. Results read in 10 minutes. LifeSign reports sensitivity of 95.9 percent and 91.6 percent overall agreement to biopsy histology for the assay. Each box holds 30 tests, and external controls are not included in the kit.
Features and Benefits
Published Performance
- Sensitivity Figure – The manufacturer reports 95.9 percent sensitivity for the antibody assay.
- Histology Agreement – Overall agreement of 91.6 percent to biopsy histology is published by LifeSign.
Point-of-Care Fit
- Small Specimen Volumes – A 25 microliter fingerstick sample keeps collection painless and quick.
- Single-Reagent Procedure – One reagent step keeps the protocol short enough for office workflow.
Product Specifications
Test Details
- Analyte: Anti-Helicobacter pylori antibodies
- Specimen: Whole blood (25 µL), serum or plasma (10 µL)
- Result Time: 10 minutes
- CLIA Category: Waived for whole blood, moderate complexity for serum and plasma
- Sensitivity: 95.9 percent, with 91.6 percent overall agreement to biopsy histology (manufacturer)
Packaging
- Tests per Box: 30
- Packaging: Sold by the box, each
- Kit Note: External controls are not included
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Why Choose the Status H. Pylori Test
Antibody status is often the first branch point in a dyspepsia workup, and a ten-minute fingerstick answer keeps that branch inside the visit. The published sensitivity and histology agreement give the result documented backing. For primary care and GI offices, that speed is the difference.
- Same-Visit Direction – A 10-minute result lets the clinician discuss next steps before the patient leaves.
- Minimal Collection Burden – A fingerstick sample avoids a draw appointment for the screening step.
- Documented Performance – Sensitivity and biopsy-histology agreement figures are published by the manufacturer.
Frequently Asked Questions
What does the assay detect?
It qualitatively detects antibodies to Helicobacter pylori in whole blood, serum or plasma. It is an antibody assay, not a direct antigen test.
What sample does it need?
A fingerstick of 25 microliters of whole blood, or 10 microliters of serum or plasma. The whole blood format is CLIA waived.
How fast are results?
Results read in 10 minutes after a single-reagent procedure. That pace suits point-of-care workups.
Are controls included?
No, LifeSign states external controls are not included with this kit. Controls are a separate item in the manufacturer's line.
How many tests are included per box?
Each box holds 30 tests. The distributor file currently flags the item as on manufacturer backorder with no ETA.
